Spirox, Inc., a company devloping devices for patients suffering from nasal obstruction, announced the publication of positive results from the first in human study of the LATERA absorbable nasal implant. LATERA is designed to support lateral nasal cartilage to address nasal valve collapse (NVC), a major contributor to nasal obstruction. The data show that patients who received LATERA had a significant and sustained reduction in nasal obstruction symptoms through 12 months with no adverse change in appearance. The results were published in the April issue of Facial Plastic Surgery – “Absorbable Implant to Treat Nasal Valve Collapse.”
NVC occurs as a result of weak nasal cartilage collapsing inward when a person inhales. NVC is one of the most frequent causes of nasal obstruction, a condition that affects more than 20 million individuals in the United Statesi alone and can reduce the quality of a patient’s everyday life.
“These results are very promising, as they demonstrate the safety and efficacy of the LATERA implant and provide an optimal approach for correcting a common cause of nasal obstruction,” says Dr. Marion San Nicoló, MD, University Clinic of Munich, LMU and Principal Investigator in the study. “I believe that the LATERA implant is an important advance that has the potential to transform the treatment of NVC.”
The study was conducted at three sites in Germany and included 30 adult patients with NVC. Patients had severe or extreme symptoms as established by the validated Nasal Obstruction Symptom Evaluation (NOSE) instrument. A total of 56 LATERA implants were placed in these 30 subjects, 26 of whom received implants on both sides of the nose. Patients were assessed at 1 week and 1, 3, 6 and 12 months post-procedure.
Key findings of the study include:
- Average NOSE score reduction of 48.4, 43.3 and 40.9 at 3, 6 and 12 months, respectively.
- Statistically significant average NOSE score reduction at 3, 6 and 12 months (p < 0.001).
- No adverse change in cosmetic appearance at 12 months post procedure.
“Spirox was founded to address the significant need for more accessible and effective treatments for the millions of people who have diminished quality of life due to nasal obstruction,” says Dr. Don Gonzales, Spirox Chief Medical Officer. “The results of this study support the LATERA implant as an important treatment option for patients who want nasal obstruction symptom relief.